Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name gauze/sponge, internal, x-ray detectable
510(k) Number K812391
Device Name NEUROSPONGES
Applicant
WINN HIRSCH & ASSOC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
WINN HIRSCH & ASSOC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4450
Classification Product Code
GDY  
Date Received08/20/1981
Decision Date 11/24/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-